FDA Approves Uceris

SAN DIEGO--(BUSINESS WIRE)--Jan 15, 2013 - Santarus, Inc. announced today that the U.S.
Food and Drug Administration (FDA) has approved
Uceris (budesonide) extended release tablets for
the induction of remission in patients with active, mild to
moderate ulcerative colitis. The company expects to commence the
commercial launch of Uceris in March 2013.

Uceris contains budesonide, a corticosteroid, in a novel oral
tablet formulation that utilizes proprietary MMX®
multi-matrix system colonic delivery technology. The approved
dosing regimen for adult patients is one 9 mg tablet taken orally
once daily in the morning for up to 8 weeks. Uceris was developed
in collaboration with Cosmo Technologies Limited, a subsidiary of
Cosmo Pharmaceuticals S.p.A.

“The FDA approval of Uceris provides an important new
therapeutic option to patients and physicians for the treatment of
active, mild to moderate ulcerative colitis,” said William J.
Sandborn, M.D., chief, division of Gastroenterology, director,
University of California San Diego (UCSD) IBD Center and professor
of clinical medicine, UCSD Health System. “Specifically,
Uceris is indicated for use in the induction of remission of active
disease, an acute phase of the disease often characterized by
cramping, bloating, diarrhea, bleeding, fatigue, weight loss and
frequent bowel movements.”

Gerald T. Proehl, president and CEO of Santarus, said, “We
are pleased to provide a new option for patients to treat the
active phase of mild to moderate ulcerative colitis. With the
incremental revenue from Uceris and continued growth in our
marketed products, we anticipate another robust year of solid
financial results for Santarus in 2013. We expect total revenues of
$320 million to $325 million, representing significant double-digit
growth over our 2012 revenue guidance."

Important Safety Information About Uceris

Uceris is a prescription corticosteroid medicine used to help
get mild to moderate ulcerative colitis under control. Uceris is
taken once daily in the morning with or without food for up to 8
weeks.

Do not take Uceris if you are allergic
to budesonide or any of the ingredients in Uceris.

Before you take Uceris, tell your
doctor if you have liver problems, are planning to have surgery,
have chickenpox or measles or have recently been near someone with
chickenpox or measles, have or had a family history of diabetes,
cataracts or glaucoma, have high blood pressure (hypertension),
decreased bone mineral density (osteoporosis), stomach ulcers, any
other medical condition, are pregnant or plan to become pregnant,
or breastfeed or plan to breastfeed.

Tell your doctor about all the
medications you take, including prescription and over-the-counter
vitamins and herbal supplements. Uceris and other medicines may
affect each other, causing side effects.

Do not eat grapefruit or drink
grapefruit juice while taking Uceris because these can increase the
level of Uceris in your blood.

Long-time use of Uceris can cause you
to have too much glucocorticosteroid medicine in your blood
(hypercorticism). Tell your doctor if you have any of the following
signs and symptoms of hypercorticism: acne, bruise easily, rounding
of your face (moon face), ankle swelling, thicker or more hair on
your body and face, a fatty pad or hump between your shoulders
(buffalo hump), or pink or purple stretch marks on the skin of your
abdomen, thighs, breasts, and arms.

When Uceris is taken for a long period
of time, the adrenal glands do not make enough steroid hormones.
Tell your doctor if you are under stress or have any symptoms of
adrenal suppression during treatment with Uceris, including
tiredness, weakness, nausea and vomiting, and low blood
pressure.

Uceris weakens your immune system.
Taking medicines that weaken your immune system makes you more
likely to get infections. Avoid contact with people who have
contagious diseases such as chickenpox or measles while taking
Uceris. Tell your doctor about any signs or symptoms of infection,
including fever, pain, aches, chills, feeling tired, or nausea and
vomiting.

If you take certain other
corticosteroid medicines to treat allergies (e.g., eczema,
rhinitis), switching to Uceris may cause your allergies to come
back. Tell your doctor if any of your allergies become worse while
taking Uceris.

Uceris is available by prescription only. For additional
information, talk to your healthcare provider and see the Full
Prescribing Information including Patient Labeling.

About Ulcerative Colitis

Ulcerative colitis is a form of chronic inflammatory bowel
disease (IBD) that produces inflammation and ulcers along the
inside of the colon, which can interfere with the normal function
of the colon. The disease typically starts to manifest in patients
as young adults. Ulcerative colitis is an intermittent disease with
periods of exacerbated symptoms, or flares, and periods that are
relatively symptom-free. Although the symptoms of ulcerative
colitis may resolve without treatment, the disease usually requires
medication to go into remission. According to the Crohn's and
Colitis Foundation of America, as many as 700,000 people in the
U.S. suffer from ulcerative colitis.

About Santarus

Santarus, Inc. is a specialty biopharmaceutical company focused
on acquiring, developing and commercializing proprietary products
that address the needs of patients treated by physician
specialists. The company's current commercial efforts are focused
on
GLUMETZA® (metformin hydrochloride extended
release tablets) and
CYCLOSET® (bromocriptine mesylate) tablets,
which are indicated as adjuncts to diet and exercise to improve
glycemic control in adults with type 2 diabetes, and on
FENOGLIDE® (fenofibrate) tablets, which is
indicated as an adjunct to diet to reduce high cholesterol. In
March 2013, the company plans to begin promoting
Uceris™ (budesonide) extended release tablets for
the induction of remission of active, mild to moderate ulcerative
colitis and ZEGERID® (omeprazole/sodium bicarbonate)
for the treatment of certain upper gastrointestinal disorders.
Safety information and full prescribing information for Santarus'
products are available at
www.santarus.com.

Santarus' product development pipeline includes the
investigational drug RUCONEST® (recombinant human C1
esterase inhibitor) for treatment of acute attacks of hereditary
angioedema. The company expects to submit a biologics license
application (BLA) to the U.S. Food and Drug Administration for
RUCONEST in the first half of 2013. Santarus is also developing
rifamycin SV MMX®, which is in Phase III clinical
testing for treatment of travelers' diarrhea. In addition, SAN-300,
the company's investigational monoclonal antibody, is in Phase I
clinical testing. More information about Santarus is available at
www.santarus.com.

Santarus cautions you that statements included in this press
release that are not a description of historical facts are
forward-looking statements.These forward-looking statements
include statements regarding anticipated sales trends and financial
results, the timing for commercial launch for Uceris and the timing
and outcome of various matters relating to Santarus' development
products, including the submission of a BLA for RUCONEST.

The inclusion of forward-looking statements should not be
regarded as a representation by Santarus that any of its plans or
objectives will be achieved.Actual results may differ
materially from those set forth in this release due to the risks
and uncertainties inherent in Santarus' business, including,
without limitation: Santarus' ability to successfully launch Uceris
and generate revenues from Uceris, ZEGERID, GLUMETZA and its other
currently promoted commercial products and its authorized generic
ZEGERID product; Santarus' ability to successfully advance the
development of, obtain regulatory approval for and ultimately
commercialize, its development-stage products, including the timing
and outcome of the Uceris Phase IIIb clinical study, the submission
of the RUCONEST BLA and the second Phase III clinical study for
rifamycin SV MMX; Santarus' ability to maintain patent protection
for its products, including the difficulty in predicting the timing
and outcome of ongoing patent litigation; Santarus' ability to
achieve continued progress under its strategic alliances, and the
potential for early termination of these agreements; Santarus'
dependence on strategic partners for certain aspects of its
development programs, including risks related to their financial
stability; adverse side effects, inadequate therapeutic efficacy or
other issues related to Santarus' products that could result in
product recalls, market withdrawals or product liability claims;
competition from other pharmaceutical or biotechnology companies
and evolving market dynamics; other difficulties or delays relating
to the development, testing, manufacturing and marketing of, and
obtaining and maintaining regulatory approvals for, Santarus'
products; fluctuations in quarterly and annual results; Santarus'
ability to obtain additional financing as needed to support its
operations or future product acquisitions; and other risks detailed
in Santarus' prior press releases as well as in prior public
periodic filings with the Securities and Exchange
Commission.

You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date
hereof.All forward-looking statements are qualified in
their entirety by this cautionary statement and Santarus undertakes
no obligation to revise or update this news release to reflect
events or circumstances after the date hereof.This caution
is made under the safe harbor provisions of Section 21E of the
Private Securities Litigation Reform Act of 1995.

Santarus®,
FENOGLIDE®,
Uceris™, and
ZEGERID®are trademarks of Santarus,
Inc.GLUMETZA®is a trademark
of Biovail Laboratories International S.r.l. licensed exclusively
in the United States to Depomed, Inc.CYCLOSET®is a trademark of
VeroScience LLC.MMX®is a
trademark of Cosmo Technologies Limited.
RUCONEST®is a trademark of Pharming
Group N.V.